K241629

ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)

510(k) number: K241629
Device name: ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)
Applicant: Ethicon Endo-Surgery, LLC PR
Product code: GAG — Stapler, Surgical
Decision date: 2024-07-03
Date received: 2024-06-06
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: General Hospital

PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K241629.pdf

Official FDA record: K241629

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.